Article 39 Vaccine MAHs shall establish authentic, accurate and complete sales records as required, and keep such records for no less than five years upon the expiration date of vaccines for reference. 

Disease prevention and control institutions, immunization entities and vaccine distribution entities shall establish authentic, accurate and complete records of acceptance, purchase, storage, distribution and supply as required, and keep such records for no less than five years upon the expiration date of vaccines for reference. 

When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the temperature monitoring records during the whole process of transportation and storage, and keep such records for no less than five years upon the expiration date of vaccines for reference; where the temperature monitoring records during the whole process of transportation and storage cannot be provided or the temperature control fails to meet the requirements, disease prevention and control institutions and immunization entities shall not accept or purchase the vaccines concerned. Instead, they shall immediately report to the drug regulatory departments and the competent health departments of the people's governments at or above the county level. 

Article 40 Disease prevention and control institutions and immunization entities shall establish routine vaccine inspection system. Vaccines that have unidentifiable packaging, fail to meet the storage temperature requirements, or have passed the expiration date, shall be isolated, labeled with warning signs, and handled in accordance with regulations of the drug regulatory department, the competent health department and competent ecological and environmental department under the State Council. Disease prevention and control institutions and immunization entities shall truthfully record the handling situation and keep the handling record for no less than five years upon the expiration date of vaccines for reference. 

Chapter V

Immunization

Article 41 The competent health department under the State Council shall formulate the national immunization program; vaccine varieties in the national immunization program shall be proposed by the competent health department under the State Council jointly with the financial department under the State Council, and released upon approval by the State Council. 

The competent health department under the State Council shall establish an expert consultation committee on the national immunization program, and set up a dynamic adjustment mechanism for vaccines in the national immunization program jointly with the financial department under the State Council. 

When implementing the national immunization program, people's governments of provinces, autonomous regions and municipalities directly under the Central Government may add vaccine varieties to their immunization program based on the need for disease prevention and control within their respective administrative regions, and release the adjustment after filing the record with the competent health department under the State Council. 

Article 42 The competent health department under the State Council shall formulate and issue guidance for immunization, so as to enhance the standardized management of immunization. 

The competent health department under the State Council shall formulate and issue immunization procedures for the national immunization program vaccines and guidelines for the use of non-immunization program vaccines. 

The competent health departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate immunization plans based on the practical situation of their respective administrative regions and file the record with the competent health department under the State Council. 

Article 43 Disease prevention and control institutions at all levels shall, as per their respective duties, carry out tasks related to immunization including publicity, training, technical guidance, monitoring, assessment, epidemiology surveys, emergency response, etc.. 

Article 44 Immunization entities shall meet the following conditions: 

(1) obtaining a practice license for a medical institution; 

(2) having physicians, nurses or village doctors who have received professional training on immunization organized by the competent health departments of people's governments at the county level and passed the examinations; 

(3) having cold storage facilities, equipment and cold storage system in conformity with the prescribed guidance for vaccine storage and transportation. 

The competent health departments of people's governments at or above the county level shall designate eligible medical institutions to undertake inoculation of immunization program vaccines within the responsible areas. Eligible medical institutions may undertake the inoculation of non-immunization program vaccines，and file the record with the competent health department which issued the practice license for a medical institution. 

Immunization entities shall strengthen internal management. They shall abide by the guidance for immunization, immunization procedures, guidelines for vaccine use and immunization plans. 

Disease prevention and control institutions at all levels shall enhance technical guidance for immunization of immunization entities and management of vaccine use. 

Article 45 Before administering vaccines, medical and healthcare professionals shall inform vaccine recipients or their guardian of the varieties, functions, contraindications, adverse reactions, stay for observation and other precautions of the vaccines to be administered, inquire the health condition of the vaccine recipients and whether they have any immunization contraindication, and truthfully record the informing and inquiry details. The vaccine recipients or their guardian shall truthfully provide information on the vaccine recipients' health condition and contraindication etc.. Where a vaccine cannot be administered due to contraindications, the medical and healthcare professionals shall give medical advice to the vaccine recipients or their guardians and truthfully record such advice. 

Before administering vaccines, medical and healthcare professionals shall, in accordance with the prescribed guidance for immunization, examine the vaccine recipient's health status, immunization contraindication, check the immunization certificate, examine the appearance, lot number and expiration date of the vaccine and syringe, and verify the recipient's name and age and the vaccine's name, specifications, dose, injection site and route of administration. Vaccine administration shall only take place after confirmation of information on the recipient, the immunization certificate and the vaccine to be administered. 

Medical and healthcare professionals shall administer vaccines for eligible recipients. Where a recipient experiences adverse reactions during stay for observation, the medical and healthcare professionals shall follow the prescribed guidance for immunization and take prompt actions for treatment. 

Article 46 Medical and healthcare professionals shall, in accordance with regulations of the competent health department under the State Council, truthfully, accurately and completely record the immunization information, including vaccine variety, the MAH, identification information of the smallest package unit, the expiration date, time of immunization, the medical and healthcare professional who administered the vaccine, the recipient etc., to ensure that the immunization information is traceable and searchable. The immunization records shall be kept for no less than five years upon the vaccine's expiration date for reference. 

Article 47 The State implements the immunization certificate system for children. Within one month after a child is born, his/her guardian shall go to the immunization entity undertaking immunization in the child's area of residence or the hospital where the child was born to obtain the immunization certificate. The immunization entity or hospital of birth shall not refuse to provide the certificate. The guardians shall keep the immunization certificate properly. 

Immunization shall be managed according to the place of residence. Where a child leaves the original place of residence, the immunization entity undertaking immunization in the present residential area shall provide immunization for the child. 

Format of the immunization certificate shall be stipulated by the competent health department under the State Council. 

Article 48 Where any child is admitted to a nursery or school, the nursery or school shall check the immunization certificate. Where any child is found to have not received immunization program vaccines as specified, the nursery or school shall report to the immunization entity undertaking immunization where the child lives or where the nursery or school is located and cooperate with the immunization entity to persuade the guardian of the child to have the child immunized as specified. Disease prevention and control institutions shall provide technical support to nurseries or schools in checking immunization certificates. 

The measures for checking immunization certificates for the admission of children to nurseries or schools shall be formulated by the competent health department under the State Council in conjunction with the education administrative department under the State Council. 

Article 49 Immunization entities shall not charge any fees for administering immunization program vaccines. 

When administering non-immunization program vaccines, immunization entities may charge an immunization service fee in addition to the fee for vaccines. The criteria for immunization service fee shall be formulated by the pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government jointly with the financial departments. 

Article 50 In order to prevent and control the outbreak or prevalence of infectious diseases based on the monitoring and early warning information of infectious diseases, the competent health departments of the local people's governments at or above the county level may carry out cluster immunization within their respective administrative regions after reporting to the people's governments at the same level for approval and filing the record with the competent health departments of the people's governments at or above the provincial level. 

Where cluster immunization is needed nationwide or across the borders of provinces, autonomous regions and municipalities directly under the Central Government, a decision shall be made by the competent health department under the State Council. 

The local people's governments at or above the county level or the competent health department under the State Council making the decision for carrying out cluster immunization shall organize relevant departments to carry out training, public education and resource deployment. 

Any entity or individual is prohibited to carry out cluster immunization without approval. 

Article 51 Where the local people's governments at or above the county level or their competent health departments need to take emergency immunization measures in the event of outbreak or prevalence of an infectious disease, laws and administrative regulations shall be followed. 

Chapter VI

Adverse Reactions Monitoring and Handling

Article 52 An adverse reaction of immunization is an adverse drug reaction that causes damage to the vaccine recipient's body tissue, organ and functions during or following the standard process of administering a qualified vaccine, for which no party involved is at fault. 

The following circumstances are not adverse reactions of immunization: 

(1) common reactions following immunization caused by the vaccine's intrinsic features; 

(2) injury to the vaccine recipient due to sub-standard vaccine quality; 

(3) injury to the vaccine recipient due to the immunization entity's incompliance with the guidance for immunization, immunization procedure, vaccine use guidelines and immunization plans; 

(4) coincidental events following immunization in recipients who were in the latent period or prodromal period of a certain disease at the time of immunization; 

(5) acute relapse of underlying diseases or worsening of disease conditions in vaccine recipients who have immunization contraindications prescribed on the vaccine package insert and who or whose guardian fails to provide truthful information about his/her health condition and the contraindication for the vaccine prior to immunization; 

(6) individual or cluster psychogenic reaction as a result of psychological factors. 

Article 53 The State strengthens the monitoring on adverse reactions of immunization. The plan for monitoring adverse reactions of immunization shall be formulated by the competent health department under the State Council jointly with the drug regulatory department under the State Council. 

Article 54 Immunization entities and medical institutions shall report to disease prevention and control institutions as required when identifying suspected adverse reactions of immunization. 

Vaccine MAHs shall set up special organization equipped with full-time staff to actively collect, track and analyze the suspected adverse reactions of immunization, take prompt risk control measures, report the suspected adverse events to disease prevention and control institutions and submit the quality analysis report to drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. 

Article 55 Disease prevention and control institutions shall promptly report the suspected adverse reactions of immunization as required, organize the investigation and diagnosis, and inform the vaccine recipient or his/her guardian of the conclusion of the investigation and diagnosis. Where there is controversy over the conclusion of the investigation and diagnosis, an application for appraisal may be submitted according to the appraisal measures formulated by the competent health department under the State Council. 

Suspected adverse reactions of immunization that have significant influence on the society including any death or severe disability of the vaccine recipient caused by immunization and suspected cluster adverse reactions of immunization shall be investigated and handled by the competent health departments and the drug regulatory departments of the people's government of the municipalities divided into districts and above as per their respective responsibilities. 

The appraisal measures for adverse reactions of immunization shall be formulated by the competent health department under the State Council. 

Article 56 The State implements a compensation system for adverse reactions of immunization. Where, during or after the immunization process, a vaccine recipient suffers from harm including death, severe disability, organ and tissue damage, etc., compensation shall be given thereto if these conditions are adverse reactions of immunization or the possibility cannot be ruled out. The scope of compensation is subject to catalogue management, and shall be adjusted based on the actual situations. 

Compensation needed for immunization of immunization program vaccines shall be included in the funding for immunization budgeted by the financial departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government; compensation needed for immunization of non-immunization program vaccines shall be paid by the vaccine MAHs involved. The State encourages compensating vaccine recipients with adverse reactions of immunization through commercial insurance and other means. 

Compensation for adverse reactions of immunization shall be prompt, convenient and rational. The scope, standards and procedures of compensation for adverse reactions of immunization shall be determined by the State Council, while the specific implementation measures shall be formulated by the provinces, autonomous regions or municipalities directly under the Central Government. 

Chapter VII

Vaccine Post-Marketing Management 

Article 57 Vaccine MAHs shall establish and improve quality management systems for whole life cycle of vaccines, formulate and implement vaccine post-marketing risk management plans, and conduct vaccine post-marketing studies to further verify the safety, effectiveness and quality management of vaccines. 

Where further study is required when a vaccine's registration application is approved, the vaccine MAH shall complete the study within the prescribed time limit; where the study fails to be completed on time or fails to prove that the benefits outweigh the risks, the drug regulatory department under the State Council shall take actions in accordance with law up to revoke the vaccine's registration certificate. 

Article 58 Vaccine MAHs shall carry out quality tracking analysis for vaccines and continuously improve quality control standards, production process and stability of the production process. 

Changes to the production process, production sites, critical equipment, etc., shall be assessed and validated, and shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council for change management; changes that may affect vaccine quality, effectiveness and quality management shall be subject to approval by the drug regulatory department under the State Council. 

Article 59 Vaccine MAHs shall continue to update the package inserts and labels based on the post-marketing study or adverse reactions of vaccines and apply for approval or file the record as required. 

The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner. 

Article 60 Vaccine MAHs shall establish the vaccine quality retrospective analysis and risk reporting system and truthfully report information on vaccine manufacture and distribution, post-marketing studies and risk management each year as required to the drug regulatory department under the State Council. 

Article 61 The drug regulatory department under the State Council may order vaccine MAHs to carry out post-marketing evaluation, or directly organize and carry out post-marketing evaluation. 

With respect to vaccines that have serious adverse reactions or jeopardize human health due to other reasons, the drug regulatory department under the State Council shall revoke the drug registration certificates of such vaccines. 

Article 62 The drug regulatory department under the State Council may organize post-marketing evaluation of vaccine varieties based on the demand for disease prevention and control as well as the development of the vaccine industry. Where a vaccine variety is found to be significantly inferior to other vaccine varieties used for the prevention and control of the same disease in terms of product design, production process, safety, effectiveness or quality management, the drug registration certificates of all vaccines of the inferior variety shall be revoked and the corresponding national drug standards shall be abolished. 

Chapter VIII

Safeguard Measures 

Article 63 To ensure the implementation of national immunization program, the people's government at or above the county level shall incorporate into the budget of the people's governments at the same level the funds needed for vaccine safety, procurement of immunization program vaccines, immunization and information-based construction.

The people's governments at county level shall grant subsidies for the village doctors and other primary immunization and healthcare personnel engaged in immunization in accordance with relevant national regulations. 

The State gives support to the immunization in economically underdeveloped areas as required. People's governments of provinces, autonomous regions and municipalities directly under the Central Government as well as people's government of municipalities divided into districts shall grant necessary financial subsidies to the work related to immunization conducted by people's governments at county level in economically underdeveloped areas. 

Article 64 Following from the epidemic tendency of infectious diseases, the people's governments of provinces, autonomous regions or municipalities directly under the Central Government shall set up projects related to immunization in their respective administrative regions, which shall fall within the ambit of the projects for the prevention and control of infectious diseases stipulated by the health department under the State Council, and ensure the implementation of such items. 

Article 65 The health department under the State Council shall, according to the plan of each province, autonomous region and municipality directly under the Central Government for the use of national immunization program vaccines, notify the demand information for national immunization program vaccines to vaccine MAHs, and the vaccine MAHs shall reasonably arrange their manufacture according to vaccine demand information. 

In the case of any risk of vaccine supply shortage, the health department under the State Council and the drug regulatory department under the State Council shall propose suggestions, and the industry and information technology department and financial department under the State Council shall take effective measures to ensure the manufacture and supply of vaccines. 

The vaccine MAHs shall organize production and ensure the vaccine supply according to law; Vaccine MAHs stopping the manufacture of the vaccine shall promptly report to the drug regulatory department under the State Council or the drug regulatory departments of the people's government of the province, autonomous region or municipality directly under the Central Government. 

Article 66 The State buildss vaccines into the stockpile of strategic materials, implementing the stockpile at the national and provincial levels. 

The industry and information technology department and financial department under the State Council shall, in accordance with the need for disease prevention and control and public health emergency preparedness, strengthen the stockpile capacity and product management of the vaccines and establish dynamic adjustment mechanism jointly with the competent health department, public security department, market regulation department and drug regulatory department under the State Council. 

Article 67 The funds allocated for the immunization arranged by the financial departments at different levels shall be earmarked for dedicated purposes, and no entity or individuals may misappropriate or occupy them. 

Relevant entities and individuals using the funds for immunization shall accept the audit supervision by the auditing administrations according to law. 

Article 68 The State implements a compulsory liability insurance system for vaccines. 

Vaccine MAHs shall buy compulsory liability insurance for vaccines as required. Where the recipients' injury is caused by quality problems, the insurance company shall pay compensation within the limits of liability insured. 

Specific measure for the implementation of compulsory liability insurance system for vaccines shall be formulated by the drug regulatory department under the State Council jointly with the health department and the insurance regulatory department under the State Council. 

Article 69 In the case of outbreaks or prevalence of infectious diseases, relevant vaccine MAHs shall manufacture and supply vaccines for the prevention and control of infectious diseases in a timely manner. Communication and transportation entities shall preferentially transport vaccines for the prevention and control of the infectious diseases. People's governments at or above the county level and relevant departments shall properly organization, coordination and support work. 

Chapter IX

Supervision and Management 

Article 70 The drug regulatory departments and health departments shall conduct administration on the whole process of vaccine development, manufacture, distribution and immunization according to their respective responsibilities and supervise vaccine MAHs, disease prevention and control institutions, and immunization entities to fulfill their obligations according to law. 

The drug regulatory departments shall conduct supervision and inspection on the vaccine quality during the process of the vaccine development, manufacture, storage, transportation, and immunization. The competent health departments shall conduct supervision and inspection on the implementation of the immunization planning system and immunization activities according to law. 

The drug regulatory departments shall strengthen the on-site inspection on vaccine MAHs. If necessary, regulatory departments may conduct extended inspections on entities or individuals who provide products or services for vaccine development, manufacture and distribution, and relevant entities and individuals shall cooperate and not reject the inspection or conceal any information. 

Article 71 The State organizes professional and specialized pharmaceutical inspector teams at both national and provincial levels, and enhance supervision and inspection on vaccines. 

The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall select and assign inspectors to the vaccine MAHs. The inspectors, who are accountable for their conducts during their stay in vaccine MAHs, shall be responsible for supervising and inspecting the implementation of good manufacturing practice for drugs, collecting vaccine quality risks and evidence for illegal behaviors, and reporting the conditions and proposing suggesting to the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. 

Article 72 Where there exists safety risks in vaccine quality management and the vaccine MAHs have not taken measures in a timely manner to eliminate them, the relevant drug regulatory departments shall take such measures as warning meetings and orders to make rectification within a time limit etc.. 

In the case of serious violation against the relevant good manufacturing practice for drugs, the drug regulatory departments shall order the suspension of the production, sales and distribution of vaccines and immediate rectification; and the manufacture, sales and distribution shall be resumed only after the rectification is completed and the results meet the requirements upon the inspection by the drug regulatory departments. 

Drug regulatory departments shall establish a credit record system for the vaccine MAHs and their responsible persons and include them into the national credit information sharing platform, release information of their serious loss of honesty according to regulations and impose joint punishment.